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Completed

NCT Number: NCT06054971

NSAA NON-Interventional Study Protocol

The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Red Nucleus Solutions

Malvern, Pennsylvania, 19355, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
  • Confirmed diagnosis of DMD
  • Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
  • Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
  • Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
  • Participant and caregiver are based in the US throughout study
  • Participant and caregiver are fluent in the English language (verbally and in writing)

Exclusion criteria

  • Non-ambulatory DMD participant at any study timepoint
  • Caregiver/participant unwilling or unable to administer/perform the NSAA
  • Anticipated deterioration of participant's ambulatory status during the study

Treatment and study plan

Remote Administration of NSAA

Other

Remote Administration of NSAA

Primary outcomes

  1. Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Red Nucleus Enterprise Solutions, LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): a Feasibility Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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